1. Field of the Invention
The present invention relates generally to sterile fluid containers and methods for sterile filling them and, specifically, to an improved disposable apparatus that can store and dispense a fluid while maintaining the sterility of it and methods for filling such apparatus in a sterile manner.
2. Brief Description of the Prior Art
A continuing problem that has plagued the medical and pharmaceutical industries has been that of maintaining sterility (absence of bacteria) in manufacturing, storing, and dispensing fluids, such as blood serum, tissue culture media, and intravenous solutions. With the increased awareness of transmitting diseases, such as Acquired Immune Deficiency Syndrome (AIDS), has come an increased awareness for not only maintaining the sterility of the fluid itself but also taking precautionary measures to prevent the transmission of diseases through the apparatus used in conjunction with such fluids.
Attempts have been made in the past to address some of the above problems. For example, Silbert, "Method and Apparatus for Sterile Handling of Fluids," U.S. Pat. No. 4,058,363 discloses a semi-circular shaped manifold assembly having a plurality of openings. The manifold is connected to a fluid container having a fluid therein which is to be handled in a sterile fashion. The manifold is further connected to a sterilizing solution container having a sterilizing solution that is introduced into the manifold assembly to sterilize all of the connections therein. One drawback to such a manifold is the necessity of having to always flush the manifold with a sterilizing solution which may or may not be effective on a particular flushing.
Another example in which artistans have attempted to address some of the problems mentioned above s Kirschner, "Means for Sterilely Transferring Blood Plasma, Serum, Biological or Pharmaceutical Fluids, and the Like," U.S. Pat. No. 3,566,930. Kirschner describes a flat elongated manifold member having a plurality of branch conduits, and check valves disposed at the juncture of each branch conduit with the manifold to regulate the flow of fluid between a plurality of storage containers and a larger pooling container. While Kirschner provides a degree of disposability, apart from the pooling container, the apparatus does not appear to be readily adaptable for integration into a continuous process for manufacturing the sterile fluid and then dispensing it. Thus, whatever sterility is maintained from the transfer of fluid from the storage containers to the pooling container is effectively lost if the sterility is not continuously maintained between the fluid source and storage containers.
Industrial processes utilize a clean room. In the clean room, receiving containers move pass a fluid dispenser in assembly line fashion to be filled with a quantity of the fluid. The containers are then sealed. This has the disadvantage of requiring a large, expensive clean room and allows for the possibility of contamination of the fluid during dispensing and then sealing.
A need therefore exists in the art to provide a apparatus that can sterilize, store, and dispense liquids in a closed environment and sterile fashion, be low in cost and thus economical for disposal after a single use, and be readily adaptable as part of a continuous manufacturing process.